Huidige banen gerelateerd aan Senior Director of Global Safety - Leiden, Zuid-Holland - Pharming Group
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Senior Director of Global Pharmacovigilance
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Associate Director QC Operations Lead
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Senior Director of Global Safety
2 maanden geleden
Pharming Group is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Our innovative portfolio of protein replacement therapies and precision medicines is in early to late-stage development, with a focus on self-development of our people, teamwork, leadership, and being results-oriented.
The RoleThe Senior Director Pharmacovigilance will lead the global safety strategy and overall safety profile for assigned Pharming products throughout their lifecycle. This includes overseeing major pre-and post-marketing safety-related deliverables, such as safety evaluation, benefit-risk evaluation, and risk management activities.
Key Responsibilities- Lead the development and implementation of global safety strategies and risk management plans.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements and industry standards.
- Manage and oversee the processing of adverse event reports, including individual case reports and aggregate reports.
- Develop and maintain relationships with regulatory authorities, including the FDA, EMA, and MHRA.
- Provide medical review and assessment of individual case reports, including seriousness, causality, and reportability.
- Prepare and submit safety reports, including PSURs and DSURs.
- Participate in audits and inspections, and maintain a current awareness of legislation and practices relating to pharmacovigilance.
- Doctor of Medicine (MD) degree, with clinical research and/or fellowship training in pharmacology or other relevant specialty.
- Excellent knowledge of pharmacovigilance operations, including case processing and reporting.
- Strong understanding of good pharmacovigilance practices (GVP) modules and current drug safety/pharmacovigilance regulations.
- Experience in planning, allocating, and managing multiple projects, with a strong ability to handle conflict situations and think strategically.
- Computer proficiency, with experience in using MedDRA and WHO Drug coding dictionaries.
We offer a permanent position with an excellent remuneration scheme, including a highly competitive salary, holiday allowance, minimum of 30 vacation days, excellent pension plan, and commuting allowance. You will also join our Learning & Development program, which offers a tailor-made development plan based on your personal and professional needs. We value a healthy life-work balance with a lot of flexibility.
